Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19) | Apply Online

Frequently Asked Questions (FAQs): Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19)

What is the IPCAVD (U19) program?

The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19) is a National Institutes of Health (NIH) funding opportunity intended to advance promising HIV/AIDS vaccine candidates beyond the usual preclinical endpoint and into early-stage human testing readiness.

What is the main goal of this funding opportunity?

The main goal is to support coordinated, translational work that moves a project from selecting a lead vaccine candidate through the major development milestones required for first-in-human studies, so investigators are positioned to begin clinical studies by the end of the award period.

Is this program meant to fund basic or exploratory preclinical research?

No. The program is not meant to fund basic or exploratory preclinical work by itself. Applications focused only on preclinical research without a credible and integrated path to early clinical evaluation are considered nonresponsive to the program's intent.

What does "integrated preclinical/clinical" mean in the context of this FOA?

It means the application is expected to connect late-stage preclinical activities to a realistic plan for early clinical evaluation. The work supported is intended to bridge the gap between a strong preclinical package and a clinical-ready product, rather than stopping at preclinical results.

What is the grant mechanism used for this opportunity?

This opportunity uses the NIH cooperative agreement mechanism (U19).

What does a U19 cooperative agreement imply about NIH's role?

A cooperative agreement generally signals that NIH expects an active partnership with awardees rather than a hands-off relationship. In other words, the program anticipates coordinated involvement consistent with a cooperative agreement structure.

What kinds of activities does IPCAVD funding support?

IPCAVD support is intended to cover practical, translational steps that often become bottlenecks, including:

• Down-selection of the vaccine candidate
• Process development steps tied to clinical translation
• cGMP manufacturing activities
• Testing and quality control
• Product release activities needed before a clinical trial can begin
• Regulatory preparation steps aligned with getting to first-in-human readiness

Does IPCAVD fund the clinical trials themselves?

No. A key boundary is that the program supports the work needed to reach the doorstep of clinical evaluation, but it does not pay for conducting the clinical trials themselves.

If clinical trials are not funded, what is expected of applicants regarding clinical studies?

Applicants are expected to line up a realistic path to run the clinical studies using other resources. The program also sets the expectation that investigators will be ready to begin clinical studies by the end of the award period, so the application should present a feasible timeline and development plan that enables that.

How can applicants plan to conduct clinical trials if the award does not fund them?

Based on the opportunity description, applicants commonly plan to run clinical studies by partnering with NIAID-supported clinical trial networks or by establishing other relationships and funding streams capable of executing the trial.

What kind of team or expertise is this program designed to support?

The program emphasizes a multidisciplinary, team-based approach because moving a vaccine into the clinic typically requires expertise across vaccine design, immunology, toxicology, process development, manufacturing, quality systems, regulatory preparation, and clinical operations.

What makes an application responsive to the program's intent?

A responsive application aligns late-stage preclinical and translational work with a credible, integrated plan to reach early clinical evaluation readiness. The intent is to move a candidate through major development milestones required for first-in-human studies, not to fund standalone preclinical research without a clear clinical path.

What kinds of plans are competitive applications expected to include?

Competitive applications are expected to include elements such as:

• A well-justified vaccine candidate selection (down-selection) strategy
• A credible manufacturing and testing plan consistent with cGMP expectations
• Clear regulatory and product release pathways
• Concrete arrangements to enable a clinical trial to start on schedule (even though the trial itself is not funded)
• A timeline and development plan that makes readiness to begin clinical studies feasible by the end of the award period

What is the Funding Opportunity Number (FOA number) for this program?

The Funding Opportunity Number is PAR-15-330.

Which NIH activity areas and CFDA numbers are associated with this opportunity?

The opportunity is tied to NIH health research activities and specifically references CFDA 93.855 (Allergy and Infectious Diseases Research) and CFDA 93.856 (Microbiology and Infectious Diseases Research).

When was this funding opportunity posted, and when did it close?

The opportunity was posted on August 14, 2015, and it had a closing date of March 9, 2018.

Is this opportunity still active?

No. The archive date is April 9, 2018, which indicates it is no longer an active, open opportunity under that posting.

How much total funding is estimated for this opportunity?

The estimated total funding listed is $2.8 million.

Is cost-sharing or matching required?

No. There is no cost-sharing or matching requirement.

Who is eligible to apply?

Eligibility is broad and includes many organization types, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) nonprofits), for-profit entities, small businesses, state and local governments, tribal governments and tribal organizations, public housing authorities, school districts, and special district governments.

Are community-serving and special-category institutions included in eligibility?

Yes. The FOA explicitly includes categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, AANAPISI organizations, tribally controlled colleges and universities, faith-based and community-based organizations, and U.S. territories or possessions.

Are non-U.S. organizations eligible?

Yes. The eligibility description explicitly includes non-U.S. entities and regional organizations.

Why is eligibility so broad for this program?

The description indicates that broad eligibility reflects how vaccine development teams are often assembled across academia, biotech, nonprofit research institutes, and global partners, particularly for diseases like HIV that can involve an international clinical footprint.

What stage of vaccine development is this program intended to support?

It is intended for vaccine candidates that are already far enough along to justify clinical translation and that need structured, integrated support to complete the expensive and highly regulated steps needed to become clinical-ready for first-in-human studies.

What is a "key boundary" of the IPCAVD program?

The key boundary described is that the program supports the work needed to reach clinical evaluation readiness but does not fund the actual conduct of clinical trials.

What does it mean to be "ready to begin clinical studies by the end of the award period"?

Within the context provided, it means the project plan, timeline, and development milestones should position the team to start early clinical studies when the award period concludes, using other resources to execute the trial itself.

What types of regulated development steps does the program highlight?

The program highlights cGMP manufacturing, testing and quality control, and product release activities, along with regulatory preparation, as key steps needed prior to starting a clinical trial.